Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients

Not Applicable

Completed

• Conditions: Fatigue; Cognitive Deficit; COVID-19; Neurophysiologic Abnormality
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)

• Registration Number: NCT05311852
• Lead Sponsor: Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy

Brief Summary

The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid

Detailed Description

Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.

Study Timeline

• Study Start: 2021-08-16
• Primary Completion: 2022-02-15
• Study Completion: 2022-03-15
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
• subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
• mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
• complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.

Exclusion Criteria

• prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions;
• clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
• anaemia;
• current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	patients were required to assume granulated placebo, 2 time/day for 8 weeks
PEA-LUT	palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)	patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks

Primary Outcome Measures

Name	Time	Method
changes in % of test amplitude in LICI 100	LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration	changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected

Secondary Outcome Measures

Name	Time	Method
change in LTP-like cortical plasticity	LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration	change of MEP modulation after intermittent theta burst stimulation (iTBS)
changes in % of test amplitude in SAI 20	SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration	changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected

Trial Locations

Locations (1)

Hospital of Vipiteno-Sterzing; 🇮🇹 Vipiteno, BZ, Italy